Anterior and Apical Prolapse: Comparison of Vaginal Mesh Surgery to Vaginal Surgery with No Mesh.

AIM OF THE STUDY: The aim of this study was to evaluate the anatomical results after an anterior sacrospinous ligament fixation (ASSLF) with native tissue repair (anterior colporraphy and apical suspension with prolene) compared to mesh repair for the correction of anterior prolapse at 12 months after surgery. MATERIALS AND METHODS: A monocentric prospective study comparing two similar cohorts who underwent ASSLF was conducted. The primary endpoint was the gain in the position of the Ba point relative to its position before surgery and twelve months after surgery. The secondary endpoints consisted of objective results, which were assessed using validated questionnaires. RESULTS: Fifty-three women were included in the native tissue repair group between June 2019 and March 2020. They were compared to 53 women operated on with anterior and apical mesh. There was no difference with respect to the Ba point after 1 year between the two groups (-2 [-3; 1.5]; -2 [-3; 1], p = 0.9789). The apex was significantly better corrected in the native tissue repair group (-7 vs. -6, p = 0.0007). There was also a better correction on the rectocele in the native tissue repair group (-3 vs. -2, p = 0.0178). The rate of Stage 2 anterior vaginal prolapse at one year was approximately 30% in both groups (no statistical difference). CONCLUSIONS: ASSFL without mesh does not increase the risk of cystocele recurrence at 1 year after surgery. A future prospective comparison of this native tissue repair technique with mesh suspension is necessary to explore these preliminary findings.

Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires. RESULTS: Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%). CONCLUSION: Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.

Prospective feasability study of ambulatory surgery for pelvic organ prolapse.

STUDY OBJECTIVE: The aim of this study was the evaluation of ambulatory surgery (AS) rate for pelvic organ prolapse (POP). DESIGN: It was a prospective observational study. DESIGN CLASSIFICATION: Level II-2. SETTING: Patients were divided in two groups: Group EAS: patients eligible to ambulatory surgery and Group NEAS: patients not eligible to AS. PATIENTS: all patients from August 2015 to November 2016 undergoing surgery for POP in our institution. MEASUREMENTS: The main outcome was overall AS rate in the population. Secondary outcomes were in NEAS group: reasons for ineligibility; in EAS group: AS success rate, reasons of failure and patient satisfaction related to AS; in each group: post operative re-admission or consultation, morbidity and global satisfaction. MAIN RESULTS: There was 157patients included in the study. Eligibility criteria for AS was met for 111/157 (707%). Overall AS rate was 58% and success rate of AS was 82%. Reasons for ineligibility to AS were lack of home support (50%), home >1 h from hospital (109%), poor home conditions (2,2%), associated comorbidity (21.7%), associated procedure (4,3%) and refusal for AS (109%). Reasons for failure (20/111, 18%) of AS were unsuccessful trial of void (TOV) (65%), post operative nausea-vomiting (PONV) (15%), sub-cutaneous emphysema (5%), post-operative bleeding (5%) and faulty organization (10%). There was no unscheduled re-admission the night after surgery in EAS group. 7,2% in EAS group and 13% in the NEAS group had an unscheduled consultation. There were 4 re-admissions (3,6%) in the EAS group and 1 (2,2%) in the NEAS group during follow-up. Patient satisfaction to AS was 100% on next-day call and 923% at 6 weeks. CONCLUSION: Ambulatory surgery rate was 58% in this population of surgically managed prolapses; AS success rate was 82%. There was no adverse events related to AS and patient satisfaction to AS at 6 weeks is high.

Long-term follow-up of patients treated by transvaginal mesh repair for anterior prolapse.

OBJECTIVE: The aim of the study was to assess 5 years outcome of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). STUDY DESIGN: This was a prospective study including all patients from January 2009 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage ≥2, according to POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/ Incontinence Sexual Questionnaire (PISQ-12). Main outcome was subjective success (question 3 of PFDI-20 score = 0). Mesh-related complications, objective and functional outcomes were used as the secondary outcomes. RESULTS: 270 patients were included in the study. Median follow-up was 5,7 years [4,5-8,2]. Subjective success rate was 86,6% at 5 years. Objective success rate was 53,1% at 5 years. At 5 years, composite failure (subjective + objective) occurred for 17 patients (12%), 7 patients with direct recurrence and 10 with indirect recurrence. Re-treatment was performed in six patients (2,8%; 3 hysterectomies for apical recurrence and 3 posterior repairs for posterior recurrence). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3,4%. At 5 years, de novo dyspareunia rate was 11,7%, 3,9% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. CONCLUSION: Five-year results demonstrate that vaginal mesh surgery provides a durable and safe repair of anterior compartment prolapse with a low rate of mesh-related complications and reoperations. Between the 2- and 5-year follow-up, patient satisfaction and associated improvements in prolapse-specific symptoms were sustained and minimal new morbidity occurred.

Two years follow up of 270 patients treated by transvaginal mesh for anterior and/or apical prolapse.

OBJECTIVE: The aim of this study was to assess the 1 and 2 years outcomes of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). MATERIAL AND METHODS: This was a prospective study including all patients from November 2008 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage≥2, according to the POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/Incontinence Sexual Questionnaire (PISQ-12). The main outcome was subjective success (question 3 of PFDI-20 score=0). Safety, anatomic and functional outcomes were used as the secondary outcomes. RESULTS: A total of 270 patients were included in the study. Subjective success rate was 95,4% and 92,2% at 1 and 2 years. Objective success rate was 65,9%and 60,5% at 1 and 2 years. At 1year, composite failure (subjective+objective) occurred for 11 patients (4,6%), 5 patients with direct recurrence and 6 with indirect recurrence. At 2 years, composite failure was reported for 14 patients (6,4%): 6 direct recurrences and 8 indirect recurrences. Re-treatment was performed in one case (0,4%). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3%. We reported a de novo dyspareunia rate of 8,4%, 5,3% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. CONCLUSION: POP repair using SIMS is a safe and efficient treatment of anterior compartment prolapse in the medium term with a low rate of mesh-related complications. Longer-term follow-up is ongoing.

Utero-vaginal suspension using bilateral vaginal anterior sacrospinous fixation with mesh: intermediate results of a cohort study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a major burden for the public health system, affecting up to 30 % of all women. One mesh kit has been introduced for pelvic organ prolapse surgery that can be inserted via a single anterior incision with the mesh arms driven through the sacrospinous ligament in a tension-free manner. The aim of this study was to describe the medium-term results of this vaginal mesh kit procedure for the combined treatment of the anterior vaginal wall and vault prolapse. METHODS: This is a longitudinal case series of patients undergoing an anterior mesh operation between 2009 and 2013. All patients presenting with symptomatic stage II prolapse or higher were included when a minimum follow-up of 12 months was achieved. A structured interview and clinical examination were performed pre- and postoperatively. RESULTS: One hundred and eighteen consecutive patients were operated with the Uphold® system during the study period. Three patients did not complete the 12-month follow-up and were excluded from the analysis, leaving 115 patients. Anatomical success at a mean follow-up of 23 months was 93 %, with a patient satisfaction rate of 95 %. Four patients (8 %) experienced de novo dyspareunia related to the mesh. The reoperation rate for mesh-related complications was 3.4 %; no patients were re-operated for POP recurrence. CONCLUSIONS: The subjective and objective cure rates were high and the mesh-related re-operation rate was 3 % in the medium term, suggesting that this surgical technique may be an option for women requiring anterior and apical prolapse repair.

Tolerance and long-term MRI imaging of gadolinium-modified meshes used in soft organ repair.

BACKGROUND: Synthetic meshes are frequently used to reinforce soft tissues. The aim of this translational study is to evaluate tolerance and long-term MRI visibility of two recently developed Gadolinium-modified meshes in a rat animal model. MATERIALS AND METHODS: Gadolinium-poly-ε-caprolactone (Gd-PCL) and Gadolinium-polymethylacrylate (Gd-PMA) modified meshes were implanted in Wistar rats and their tolerance was assessed daily. Inflammation and biocompatibility of the implants were assessed by histology and immunohistochemistry after 30 days post implantation. Implants were visualised by 7T and 3T MRI at day 30 and at day 90. Diffusion of Gadolinium in the tissues of the implanted animals was assessed by Inductively Coupled Plasma Mass Spectrometry. RESULTS: Overall Gd-PMA coated implants were better tolerated as compared to those coated with Gd-PCL. In fact, Gd-PMA implants were characterised by a high ratio collagen I/III and good vascularisation of the integration tissues. High resolution images of the coated mesh were obtained in vivo with experimental 7T as well as 3T clinical MRI. Mass spectrometry analyses showed that levels of Gadolinium in animals implanted with coated mesh were similar to those of the control group. CONCLUSIONS: Meshes coated with Gd-PMA are better tolerated as compared to those coated with Gd-PCL as no signs of erosion or significant inflammation were detected at 30 days post implantation. Also, Gd-PMA coated meshes were clearly visualised with both 7T and 3T MRI devices. This new technique of mesh optimisation may represent a valuable tool in soft tissue repair and management.

Permanent polymer coating for in vivo MRI visualization of tissue reinforcement prostheses.

The clinical advantage of MRI visualization of prostheses in soft tissue prolapses is very appealing as over 1,000000 MRI-transparent synthetic meshes are implanted annually, and postoperative complications such as mesh shrinkage and migration are frequent. Here, the synthesis of a new material composed of a DTPA-Gd complex grafted onto a backbone of PMA via a covalent bond is described (DTPA-Gd-PMA). This new polymer is sprayed onto meshes and gives an MR signal for a long period without any significant release of Gd. In vitro cytocompatibility tests on fibroblasts show limited cytotoxicity. Microscopic investigations indicate that vital cells rapidly colonize the material. Finally, coated meshes implanted in rats are easily recognizable using an MR imaging system.